balloon dilatation of the stenotic portion of a coronary artery or . bypass graft stenosis for the purpose of improving myocardial perfusion;
balloon dilatation of a coronary artery occlusion for the purpose ● of restoring coronary flow in patients with ST-segment elevation myocardial infarctions;
balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only).

Device Description

The NC TREK OTW Coronary Dilatation Catheter is an over-the-wire (OTW) co-axial design with a balloon at the distal tip. The balloon segment expands to a known diameter and length at a specific inflation pressure and has two radiopaque markers under the balloon to aid in positioning the balloon in a stenosis. The co-axial shaft consists of a tubular inner and outer member. The inner lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. Along the proximal portion of the shaft are brachial and femoral markers to aid in gauging the catheter's position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. An adaption arm is located at the proximal end to provide access to the inflation lumen and guide wire lumen and allows connection with an inflation device.

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria in the context of an AI/ML medical device. The document is a 510(k) summary for a non-AI medical device, specifically the NC TREK™ OTW Coronary Dilatation Catheter, which is a balloon catheter used for coronary artery procedures.

The information provided relates to:

Device Description: An over-the-wire co-axial design with a balloon at the distal tip for coronary dilation.
Indications for Use: Balloon dilation of stenotic coronary arteries/bypass grafts, coronary artery occlusions (for ST-segment elevation myocardial infarctions), and balloon dilation of stents after implantation.
Technological Characteristics: Claims substantial equivalence to predicate devices in product performance, design, and intended use.
Performance Data:
- Biocompatibility Testing: Included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility, complement activation, and pyrogenicity according to ISO 10993-1:2009 and FDA guidance.
- In Vitro Bench Testing: Included catheter preparation, balloon inflation/deflation, catheter shaft fatigue/rupture, distal/proximal adaption tensile, inner member collapse, kink and flexibility, torque, and catheter coating particulate/integrity.
- Conclusion: Stated that the device "met all acceptance criteria and performed similarly to the predicate devices" and that "no new safety or effectiveness issues were raised."

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and an AI/ML-related study as those details are not present in the provided text. The document describes a traditional medical device submission (a PTCA catheter) and its associated non-AI performance testing.

Summary

{0}------------------------------------------------

K113464
p. 1 of 3

SECTION 2 – 510(k) SUMMARY

MAR - 6 2012

The 510(k) Summary is submitted in accordance with 21 CFR 807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.

1. SUBMITTER'S NAME	Abbott Vascular
2. SUBMITTER'S ADDRESS	26531 Ynez Road, Temecula, CA 92591
3. TELEPHONE	(951) 914-3243
4. FAX	(951) 914-0339
5. CONTACT PERSON	Suzanne Redman
6. DATE PREPARED	November 18, 2011
7. DEVICE TRADE NAME	• NC TREK™ OTW Coronary DilatationCatheter
8. DEVICE COMMON NAME	• Coronary Dilatation Catheter• Percutaneous Transluminal CoronaryAngioplasty (PTCA) Catheter
9. DEVICE CLASSIFICATIONNAME	PTCA Catheter, LOX, Class II,21 CFR 870.5100
10. PREDICATE DEVICE NAME	• NC TREK™ RX Coronary DilatationCatheter• TREK™ OTW Coronary Dilatation Catheter• MINI TREK™ OTW Coronary DilatationCatheter• VOYAGER® NC Coronary DilatationCatheter

11. DEVICE DESCRIPTION

The NC TREK OTW Coronary Dilatation Catheter is an over-the-wire (OTW) co-axial design with a balloon at the distal tip. Table 2-1 provides a matrix of the balloon diameters and lengths available for the NC TREK OTW family of devices.

{1}------------------------------------------------

BalloonDiameter(mm)	Balloon Length
	6mm	8mm	12mm	15mm	20mm	25mm
Single Layer Balloon
1.50	X	X	X	X	X
2.00	X	X	X	X	X
2.25	X	X	X	X	X
2.50	X	X	X	X	X	X
2.75	X	X	X	X	X
3.00	X	X	X	X	X	X
3.25	X	X	X	X	X
Dual Layer (Co-Extruded) Balloon
3.50	X	X	X	X	X	X
3.75		X	X	X	X
4.00		X	X	X	X
4.50		X	X	X	X
5.00		X	X	X	X

Table 2-1	NC TREK OTW Size Matrix
-----------	-------------------------

The balloon segment expands to a known diameter and length at a specific inflation pressure and has two radiopaque markers under the balloon to aid in positioning the balloon in a stenosis. The co-axial shaft consists of a tubular inner and outer member. The inner lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. Along the proximal portion of the shaft are brachial and femoral markers to aid in gauging the catheter's position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. An adaption arm is located at the proximal end to provide access to the inflation lumen and guide wire lumen and allows connection with an inflation device.

INDICATIONS FOR USE 12.

The NC TREK OTW Coronary Dilatation Catheter is indicated for:

balloon dilatation of the stenotic portion of a coronary artery bypass graft stenosis for the . purpose of improving myocardial perfusion;
balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary . flow in patients with ST-segment elevation myocardial infarctions; and,
balloon dilatation of a stent after implantation (balloon models 2.0 mm 5.0 mm only). .

13. TECHNOLOGICAL CHARACTERISTICS

Comparisons of the new and predicate devices show that the technological characteristics such as product performance, design and intended use are substantially equivalent to the current marketed predicate devices.

{2}------------------------------------------------

14. PERFORMANCE DATA

Summary of Biocompatibility Testing 14.1

Biocompatibility testing included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility, complement activation, and pyrogenicity according to the recommendations of Guidance for Industry and FDA Staff - Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010 and ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing.

Summary of In Vitro Bench Testing 14.2

The NC TREK OTW Coronary Dilatation Catheters were subjected to the following in vitro bench tests according to the requirements of Guidance for Industry and FDA Staff-Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010:

Catheter Preparation �
Balloon Inflation / Balloon Deflation .
Catheter Shaft Fatigue .
Catheter Shaft Rupture .
Distal Catheter Tensile .
. Proximal Adaption Tensile
Inner Member Collapse .
. Kink and Flexibility
. Torque
Catheter Coating Particulate .
Catheter Coating Integrity .

14.3 Performance Testing - Conclusion

These biocompatibility and in vitro bench testing results demonstrated that the NC TREK OTW Coronary Dilatation Catheters met all acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing program and, therefore, these devices may be considered substantially equivalent to the predicate devices.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAR - 6 2012

Abbott Vascular, Inc. c/o Ms. Suzanne Redman Regulatory Affairs Project Manager 26531 Ynez Road P.O. Box 9018 Temecula, CA 92591

Re: K113464

Trade Name: NC TREK™ OTW Coronary Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: PTCA Catheters Regulatory Class: Class II . Product Code: LOX Dated: February 22, 2012 Received: February 23, 2012

Dear Ms. Redman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{4}------------------------------------------------

Page 2 - Ms. Suzanne Redman

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issumos of a bacevice with other requirements of the Act that FDA has made a decemmadon that your federal agencies. You must comply of ally I ederal Statutes and regulations and limited to: registration and listing (21 CFR with an the Act s requirements, moraining, son Levice reporting (reporting of medical device-Fall 807), labeling (21 CFR 803); good manufacturing practice requirements as set forth in related adverse events) (21 CFR 003); good names. In applicable, the electronic product
the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1950 the quality systems (QS) regarations 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific da not 10 your le mters offices/CDRH/CDRHOffices/ucm115809.htm for go to intep://www.tda.gov/rtoour.boutcal Health's (CDRH's) Office of Compliances. Also, please the Center for Devilocs and Radioronding by reference to premarket notification" (21CFR Part note the regulation regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the r ou may ookin of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M. A. Hillerman

& Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

SECTION 1 - INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Names:

NC TREK™ OTW Coronary Dilatation Catheter

Indications for Use:

The NC TREK™ OTW Coronary Dilatation Catheter is indicated for:

balloon dilatation of the stenotic portion of a coronary artery or . bypass graft stenosis for the purpose of improving myocardial perfusion;
balloon dilatation of a coronary artery occlusion for the purpose ● of restoring coronary flow in patients with ST-segment elevation myocardial infarctions;
balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only).

X Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter (Optional Format 1-1-96)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.J. Hillen

(Division Sign-Off) Division of Cardiovascular Devices

11113464 510(k) Number

Page __ of

1-1

Regulation Number and Section

§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.

(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.